MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS

Intraocular Lens

FDA Premarket Approval P910061

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceMODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantBAUSCH & LOMB
Date Received1991-10-08
Decision Date1994-09-02
Notice Date1994-10-14
PMAP910061
SupplementS
Product CodeHQL
Docket Number94M-0339
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address BAUSCH & LOMB 50 Technology Drive irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P910061Original Filing
S027 2021-12-22 30-day Notice
S026 2020-12-11 30-day Notice
S025 2019-01-04 30-day Notice
S024
S023 2016-05-31 30-day Notice
S022 2015-10-15 30-day Notice
S021
S020 2013-07-31 30-day Notice
S019 2009-11-02 30-day Notice
S018 2009-06-09 30-day Notice
S017 2008-06-19 30-day Notice
S016 2008-04-03 30-day Notice
S015 2006-08-30 Real-time Process
S014 2006-04-03 Real-time Process
S013 2006-03-30 Real-time Process
S012 2004-03-29 Normal 180 Day Track No User Fee
S011 2004-03-18 Real-time Process
S010 2003-06-23 30-day Notice
S009 2003-06-11 Real-time Process
S008 1999-02-10 Real-time Process
S007 1998-12-18 Normal 180 Day Track
S006 1998-12-01 Real-time Process
S005 1998-10-29 135 Review Track For 30-day Notice
S004 1998-09-18 Real-time Process
S003 1998-08-07 Normal 180 Day Track
S002
S001 1997-06-10 Normal 180 Day Track

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